Hospitalized patients faced with sudden inability to speak (e.g., patients with tracheal intubation) are unable to verbalize even the most basic comfort and care needs, or their urgent safety needs. These patients and nursing staff must consequently resort to alternative nonverbal communication strategies such as gestures, mouthing words, or the use of alphabet boards, which are slow, energy-draining, and ineffective. These strategies are also inadequate for expressing emergent, life-threatening needs such as inadvertent disconnection of ventilators/oxygen or a blocked airway. Currently, no standards of practice, commonly used best practices, or software/devices exist to facilitate the care of suddenly speechless (SS) patients. Clearly, current practice lacks effective approaches to prevent and rapidly treat dangerous situations in this highly vulnerable population and to lessen patients'frustration, anxiety, fatigue, and dissatisfaction with provided care. The purpose of this innovative project is to (1) advance development initiated during our Phase1 SBIR grant # 1R42NR010842-01 of communication software uniquely designed for this population, conduct a research study to determine whether GatorVoice improves SS patients ability to communicate with nursing staff, and produce a commercially viable communication device. Based on our Phase I project, GatorVoice is the first solution of its kind tailored specifically to communicate the needs of SS patients. Our pilot study demonstrated the feasibility of GatorVoice in the hospital setting. In addition, it will be the first system to provide data capturing from patient-staff interactions that can be organized as summary reports and printed out by nurses for use during shift reports. The project's emphasis is consistent with NINR's research focus including: 1) "seeking ways to reduce the burden of illness and disability by understanding and easing the effects of acute and chronic illness" and 2) "technologies to be used in the hospital... that improve symptom evaluation in persons with chronic conditions" (Omnibus Solicitation for SBIR/STTR Grant Applications, 2010). A study is proposed to examine the effectiveness of GatorVoice in facilitating the communication process for SS patients. A quasi-experimental study will be conducted with SS participants using GatorVoice and a control group of SS participants using current communication methods, e.g., paper/pen, gestures (and an Urgent Button developed for this study) to communicate. Outcome measures will be ease of communication, frustration with communication, and satisfaction with communication method. In a qualitative study, we will examine nurses'experiences with communicating with SS patients, and the impact that communication methods have on that process. An iterative process of product development and clinical testing will be used throughout Phase to advance maturation of GatorVoice software and integration into one or more hardware platforms, thereby bringing the system to the commercial stage. PUBLIC HEALTH RELEVANCE: Currently, hospitals do not have effective or reliable methods to assist patients faced with sudden inability to verbalize their needs. The purpose of this project is to continue development of a communication product that will assist suddenly speechless hospitalized patients to effectively communicate their needs, test the device with patients in the hospital, and produce a viable product for commercialization. Availability of a reliable communication method at a time when critical needs surface (e.g. breathing difficulty) has significant potential to improve patient safety and other essential communication between patients and nursing staff.